As Americans continue to step up to help each other stay healthy, distillers have started producing hand sanitizer to help meet the overwhelming demand and further equip health care professionals, first responders, and local and state governments with more resources.

While a provision in the recently passed Coronavirus Aid, Recovery, and Economic Security (CARES) Act temporarily removed a federal excise tax on distillers that follow FDA guidance in producing hand sanitizer, the FDA’s guidance effectively limits distillers to using denatured (non-food-grade) alcohol, despite the World Health Organization (WHO) recognizing the use of undenatured (food-grade) alcohol as an acceptable ingredient in hand sanitizer.

In their letter, Dr. Paul and his fellow senators note that undenatured alcohol is what distillers “have readily available,” and they call on the FDA to update its guidance to recognize this reality and “work with industry on reasonable safeguards” to protect children.

As the senators make clear, “[A]ny FDA guidance should help facilitate both the production of hundreds of thousands of gallons of hand sanitizer and the distribution to those on the front lines battling this pandemic while simultaneously protecting consumers. We have a responsibility to provide more resources to help flatten the curve and alleviating this burden would allow distilleries the opportunity to step up and help their communities.”

“I’m proud of how Kentuckians are answering the call to action during this emergency, and I will continue working to remove the obstacles in their way. I urge the FDA to act immediately to reduce distillers’ costs to make hand sanitizer, which will enable them to ramp up production and help protect more Americans, especially those on the frontlines of this fight,” said Dr. Paul.

“We appreciate the support of Sen. Paul and his Senate colleagues in calling on the FDA to be more flexible during this crisis so we can get hand-sanitizer to those who need it most,” said Distilled Spirits Council of the United States President and CEO Chris R. Swonger.

You can read the senators’ letter below:

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Dear Commissioner Hahn:

We write regarding the U.S. Food and Drug Administration’s (FDA) guidance to manufacturers who are producing hand sanitizer as part of the COVID-19 crisis. As you know, hundreds of distilled spirits producers across the country have immediately responded to the current health crisis by halting their regular operations and quickly turning to the production of hand sanitizer. These distillers are fulfilling a critical need in their communities and providing the hand sanitizer to health care professionals, first responders, and local and state governments. They have diligently followed the guidance released by their regulator, the Alcohol, Tobacco Tax and Trade Bureau (TTB), and are producing hand sanitizer according to the World Health Organization’s (WHO) formula.

Unfortunately, the FDA’s “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19): Guidance for Industry” does not acknowledge the reality that these distillers have stepped up in a time of crisis to produce hand sanitizer using the alcohol they have readily available, which is undenatured. Undenatured alcohol is food grade alcohol that is compliant with the WHO’s hand sanitizer formula and has the same effectiveness as denatured alcohol. The United States largely differentiates between the two types of alcohol for tax purposes – with undenatured alcohol incurring the distilled spirits Federal Excise Tax (FET) and paid to the federal government.

A provision was included in the recently-passed CARES Act that would temporarily remove the Federal Excise Tax on hand sanitizer production as long as the distiller has followed FDA guidance. Therefore, any FDA guidance should help facilitate both the production of hundreds of thousands of gallons of hand sanitizer and the distribution to those on the front lines battling this pandemic while simultaneously protecting consumers. We have a responsibility to provide more resources to help flatten the curve and alleviating this burden would allow distilleries the opportunity to step up and help their communities.

We strongly urge the agency to update its guidance to recognize the use of undenatured alcohol in the production of hand sanitizer during the COVID-19 health crisis and work with industry on reasonable safeguards to keep hand sanitizer out of the hands of children. This will ensure distillers do not face a tax bill for filling a vital need in their communities.

Thank you for your consideration of this change. Please do not hesitate to contact our offices if we can be of additional assistance.